With the drug substance converted into the final drug product at the facility, a focus on quality is essential as these are the products being used by the patients. This is a message the firm is keen to instil in its workers.
“If you don’t feel that you could inject that into yourself or family then you don’t belong here,” said Jeong Won Yun.
Therefore, workers receive training on standard operating procedures on a regular basis, and a number of signs posted around the site reiterate the importance of quality in both Korean and English.
The facility only hires operational staff with a proficient level of English as Celltrion deals with a lot of English speaking regulatory inspectors and, Jeong Won Yun said, operators have to be able to communicate with them.
“As the first biosimilar company per se, most inspectors sent over were senior inspectors, looking into this ‘new’ product.”